(29 days)
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The ACUSON AcuNav Volume ICE Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time three-dimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time twodimensional images. The Change Being Effected is the addition of a clarification instruction for the use of the introducer in the catheter device User Manual and Directions for Use.
This document describes the regulatory submission for the Siemens ACUSON AcuNav Volume Intracardiac Echocardiography Catheter. The submission is for a modification to an already cleared device (K173618), specifically adding a clarification instruction in the user manual regarding the use of an introducer.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission is for a labeling change to an already cleared device, and states that the device itself is unchanged, the "acceptance criteria" here refer to the demonstration of continued compliance with safety standards and the non-introduction of new safety or effectiveness concerns due to the labeling change. There are no new performance metrics reported for the device itself in this submission.
| Acceptance Criteria (Demonstrated) | Reported Device Performance (Compliance) |
|---|---|
| Device remains unchanged (technology, patient contact materials, principles). | Confirmed |
| Acoustic output verified. | Conforms to AIUM/NEMA UD-3, UD-2 |
| Biocompatibility verified. | Conforms to ISO 10993-1 |
| Cleaning and disinfection effectiveness verified. | (Implicitly maintained from predicate) |
| Thermal, electrical, electromagnetic, and mechanical safety verified. | Conforms to UL 60601-1, IEC 60601-2-37, EN/IEC 60601-1, EN/IEC 60601-1-2 |
| Sterilization of health-care products verified. | Conforms to ISO 11135 |
| Packaging for terminally sterilized medical devices verified. | Conforms to ISO 11607-1 and ISO 11607-2 |
| The labeling change does not impact substantial equivalence of the catheter device. | Confirmed |
| The labeling change does not introduce new safety and effectiveness concerns. | Confirmed |
2. Sample size used for the test set and the data provenance
No new test set data was generated or used for this specific submission because the device itself is unchanged, and the submission is for a labeling modification. The substantial equivalence is based on the predicate device, K173618.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set data requiring expert review was generated for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set data requiring adjudication was generated for this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ultrasound catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ultrasound catheter, not an algorithm, and does not operate in a standalone algorithmic fashion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable to this submission, as it focuses on demonstrating continued safety and equivalence for a labeling change rather than new clinical performance data. The original predicate device's substantial equivalence would have been based on clinical experience and performance data typical for diagnostic intravascular catheters, but this detail is not provided in this document.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the (continued) acceptance criteria is primarily non-clinical testing and a comparative analysis against the predicate device (K173618).
- Rationale for the study: The submission states that "The catheter device remains unchanged from previously cleared submission for the predicate device, AcuNav Volume ICE Catheter (K173618). The Change Being Effected is the addition of a warning to clarify the proper use of the introducer used with the catheter device and does not introduce new safety and effectiveness concerns."
- Nature of the study: The "study" involves demonstrating that the modified device (with the labeling clarification) maintains substantial equivalence to the predicate device. This is achieved by:
- Verification of Unchanged Device Characteristics: Confirming that the device's technology, patient contact materials, and principles of operation are identical to the predicate.
- Compliance with Safety Standards: The document lists adherence to numerous voluntary standards for acoustic output, biocompatibility, cleaning/disinfection (implicitly maintained), thermal, electrical, electromagnetic, and mechanical safety, as well as sterilization and packaging. These standards were presumably met by the predicate device and the unchanged hardware.
- Evaluation of the Labeling Change Impact: A critical aspect is the assessment that the addition of the clarification instruction in the user manual "does not impact the substantial equivalence of the catheter device as currently cleared under K173618" and "does not introduce new safety and effectiveness concerns." This is a regulatory determination based on reviewing the proposed labeling change.
- Conclusion: "Because the AcuNav Volume ICE catheter in this submission uses the same technology, patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence." This statement directly indicates that the "study" for this submission focuses on non-clinical aspects and the lack of change in the device itself, making new clinical performance data unnecessary for proving continued acceptance.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).